IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome

NCT06451198 | Recruiting Phase 4 DMC

• 1 other identifier: B2024-187
• Study Type: interventional
• Target: 2,846
• Locations: 1 country
• Sites: 1

Brief Summary

The OPTION2 trial (randomized controlled trial of IndObufen versus asPirin after coronary drug-eluting stent implantaTION in elderly patients with acute coronary syndrome) was designed to compare the 1-year clinical efficacy and safety of indobufen-based dual antiplatelet therapy (DAPT) (indobufen 100mg bid plus ticagrelor 90mg bid) or conventional DAPT (aspirin 100mg qd plus ticagrelor 90mg bid) in acute coronary syndrome (ACS) patients aged over 65 years old undergoing coronary drug-eluting stent (DES) implantation.

Conditions

Coronary Artery Disease; Antiplatelet Drugs

Outcome Measures

Primary Outcomes (1)

• net adverse clinical events (NACEs)

  including ischemic and bleeding events, i.e., a composite of cardiovascular (CV) death, nonfatal myocardial infarction (MI), ischemic stroke, definite or probable stent thrombosis (ST), or Bleeding Academic Research Consortium (BARC) criteria type 2, 3 or 5 bleeding

  1-year

Secondary Outcomes (4)

• a composite of CV death, nonfatal MI, ischemic stroke, definite or probable ST

  1-year

• BARC criteria type 2, 3 or 5 bleeding events

  1-year

• a composite endpoint of CV death, nonfatal MI, ischemic stroke, definite or probable ST, or BARC criteria type 3 or 5 bleeding

  1-year

• all-cause mortality

  1-year

Study Arms (2)

indobufen plus ticagrelor

EXPERIMENTAL

Patients meeting the criteria are randomized before discharge from the hospital and given indobufen 100 mg bid and ticagrelor 90mg bid the second day after randomization. The administration shall last 12 months.

Drug: Indobufen; Drug: Ticagrelor

aspirin plus ticagrelor

ACTIVE COMPARATOR

Patients meeting the criteria are randomized before discharge from the hospital and continued aspirin 100 mg qd and ticagrelor 90mg bid. The administration shall last 12 months.

Drug: Aspirin; Drug: Ticagrelor

Interventions

Ticagrelor DRUG

All the patients meeting the criteria and enrolled in the study are given ticagrelor 90mg bid for 12 months.

aspirin plus ticagrelor; indobufen plus ticagrelor

Indobufen DRUG

Patients meeting the criteria are randomized before discharge from the hospital and given indobufen 100mg bid and ticagrelor 90mg bid the second day after randomization. The administration shall last 12 months.

indobufen plus ticagrelor

Aspirin DRUG

Patients meeting the criteria are randomized before discharge from the hospital and continued aspirin 100 mg qd and ticagrelor 90mg bid. The administration shall last 12 months.

aspirin plus ticagrelor

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age over 65 years old
• Diagnosed with acute coronary syndrome (unstable angina/ non-ST elevation myocardial infarction/ ST elevation myocardial infarction)
• Treated with at least 1 DES implanted in the coronary lesion
• Receiving dual antiplatelet therapy (aspirin plus ticagrelor)
• Agree to attend the trial

You may not qualify if:

• Elective surgical procedure planned within 12 months
• Life expectancy ≤1 year
• Known allergy or intolerance to aspirin, ticagrelor or nonsteroidal anti-inflammatory drugs (NSAIDs)
• History of cerebral hemorrhage
• History of stroke in six months
• Active bleeding
• Known relevant hematological deviations
• Known, clinically important thrombocytopenia (i.e., \<100\*10\^9/L) or anemia (i.e., \<90g/L)
• Active cancer
• Concomitant use of oral anticoagulants
• Active participation in another clinical study
• Other situations in which the investigator considers unsuitable to attend the study

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

indobufen; Aspirin; Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

Lili Xu, Dr

CONTACT

8615901823966; lilixu1991@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 11, 2024
• Study Start: May 19, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)